Citicholine-Amantadine Trial in Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Galsgow coma scale
研究概览
简要总结
This randomized study aims at comparing between the effects of amantadine, citcholine and its combinations on arousal and behavioral consequences in early phase of moderate Traumatic Brain injury (TBI).
详细描述
As both agents amantadine and citcholine showed considerable effects on neuro-recovery from TBI, The investigators hypothesized that combination therapy of both drugs will have significant effect as it simultaneously will target multiple mechanisms of injury. So, this randomized study aims at comparing between the effects of amantadine, citcholine and their combinations on arousal and behavioral consequences in early phase of moderate TBI
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained moderate non-penetrating TBI with GCS of 9-12
排除标准
- •Patients with mild (GCS > 12) or severe TBI (GCS < 9)
- •Patients suffering from any central nervous system disability prior to the traumatic brain injury
- •Major medical problems as; major cardiovascular disease or heart failure, renal insufficiency (creatinine clearance, less than 60 ml per minute), liver impairment,
- •Pregnancy,
- •More than one seizure in the previous month,
- •Prior treatment with amantadine,
- •Allergy to the study drugs.
研究组 & 干预措施
Group C
Citicholine Drug
干预措施: Citicholine (Drug)
Group A
Amantadine Drug
干预措施: Amantadine (Drug)
Group D
Both Citocholine and Amantadine
干预措施: Citicholine (Drug)
Group D
Both Citocholine and Amantadine
干预措施: Amantadine (Drug)
结局指标
主要结局
Galsgow coma scale
时间窗: 30 days
Neurological scale which aims to give a reliable and objective way of recording the conscious state of a person for initial as well as subsequent assessment. A patient is assessed against the criteria of the scale, and the resulting points give a patient score between 3 (indicating deep unconsciousness) and 15 (full conscious).
次要结局
- disability rating scale (DRS)(30 days)
- Mini Mental scale (MMS)(30 days)
研究者
Dina Salah Eldin Mahmoud Badre
Assistant Professor
Ain Shams University